Improvement of long-term outcome in schizophrenia: switching to risperidone long-acting injectable

Background

Risperidone microspheres represents the first long-acting injectable preparation of an atypical antipsychotic. The Switch to Risperidone Microspheres (StoRMI) trial investigated the maintained efficacy and safety of this formulation of risperidone long-acting microspheres in patients with schizophrenia or other psychotic disorders when swhitchingswitching from typical depot or oral neuroleptics to long-acting risperidone microspheres. We report here the results of a subgroup analysis of Greek patients.

Materials and methods

Patients who were symptomatically stable on any previous antipsychotic medication for >/ = 1 month received intramuscular injections of long-acting risperidone 25 mg (increased to 37.5 or 50 mg, if necessary) every two weeks for 6 months. Previous antipsychotics were continued concomitantly during the first 3 weeks of long-acting risperidone therapy.

Results

The analysis included 91 male and 31 female patients of mean age 42.5 years. The majority of patients had schizophrenia (84%; mostly paranoid according to DSM-IV criteria). Other diagnoses were schizoaffective disorder (9%) and other psychotic disorders (8%). Previous antipsychotic therapy was mostly atypical antipsychotics (72%) as well as conventional depot and oral antipsychotics. Reasons for switching were mainly (66%) non-compliance with previous therapy (66%), insufficient efficacy (22%) and side effects (18%). The majority of patients (77%) completed the 6-months period of therapy; most common reasons for discontinuation were adverse events (9%), withdrawal of consent (8%), and patients lost to follow-up (6%). There were significant reductions from baseline (p < 0.001) at 1, 3, and 6 months in mean scores for the total PANSS as well as for positive, negative and general psychopathology subscales. At endpoint, 73% of patients had >20% improvement in PANSS total scores. According to the Clinical Global Impression (CGI), patients improved significantly (p < 0.001) with the group classified as "not ill/borderline ill" rising from 2.5% at baseline to 16% at endpoint. There were significant improvements from baseline to endpoint (p < 0.0001) in all components of SF-36 Quality of Life Questionnaire. Global Assessment of Function (GAF) and patient satisfaction also increased significantly (p < 0.0001) from baseline. No unexpected adverse events were reported and the ESRS total scores of ESRS were reduced significantly (p < 0.005) from baseline at all visits.

Discussion

Switching to long-acting injectable risperidone was associated with significant improvement of symptoms. Efficacy was not only maintained but patients showed further, significant, sustained improvement of symptoms after switching. Patient satisfaction was significantly higher at endpoint than at baseline.